A film-based intervention to reduce child maltreatment among migrant and displaced families from Myanmar: Protocol of a pragmatic cluster randomized controlled trial

Background Child maltreatment is a global public health crisis with negative consequences for physical and mental health. Children in low- and middle-income countries (LMIC)–particularly those affected by poverty, armed conflict, and forced migration–may be at increased risk of maltreatment due to heightened parental distress and disruptions to social support networks. Parenting interventions have been shown to reduce the risk of child maltreatment as well as improve a range of caregiver and child outcomes, yet large-scale implementation remains limited in low-resource displacement settings. This study will examine the impact of an entertainment-education narrative film intervention on reducing physical and emotional abuse and increasing positive parenting among migrant and displaced families from Myanmar living in Thailand. Method The study is a pragmatic, superiority cluster randomized controlled trial with approximately 40 communities randomized to the intervention or treatment as usual arms in a 1:1 ratio. Participating families in the intervention arm will be invited to attend a community screening of the film intervention and a post-screening discussion, as well as receive a poster depicting key messages from the film. Primary outcomes are changes in physical abuse, emotional abuse, and positive parenting behaviour. Secondary outcomes include caregiver knowledge of positive parenting, caregiver attitudes towards harsh punishment, caregiver psychological distress, and family functioning. Outcomes will be assessed at 3 time points: baseline, 4 weeks post-intervention, and 4-month follow up. A mixed methods process evaluation will be embedded within the trial to assess intervention delivery, acceptability, perceived impacts, and potential mechanisms of change. Discussion To our knowledge, this study will be the first randomized controlled trial evaluation of a film-based intervention to reduce child maltreatment among migrant and displaced families in a LMIC. An integrated knowledge translation approach will inform uptake of study findings and application to potential scale up pending evaluation results. Trial registration The study was prospectively registered with the Thai Clinical Trials Registry on 22 February 2023 (TCTR20230222005).

In addition to the revisions made in response to reviewers' comments, we have also made the following revisions to the protocol and study design since our original submission due to the evolving conditions in the study setting.These revisions and their rationale are outlined below: 1. Removal of adolescent reports at T2: The original protocol specified that adolescent children of adult participants will be surveyed at T2.Since submitting the original protocol, security and extreme weather conditions in the study setting have made field data collection more challenging.Upon consultation with the field data collection team and local partner organizations, we decided to remove adolescent data collection from the study design.
Analysis of adolescent-reported data would have been exploratory in any case, given that we would only be able to collect data from a subsample of children who met the eligibility criteria of being between 12 and 17 years old.Hence, we would not have had statistical power to conduct a robust analysis using adolescent reported data.Given the challenges in the study setting and mindful of the wellbeing of the field team, we therefore made the decision to drop the adolescent survey.We will continue to conduct focus group discussions with adolescents, as described in the protocol, to obtain qualitative perspectives and experiences of adolescents.

Inclusion of parent-reported child internalizing and externalizing symptoms at T2:
The original protocol specified that adolescent-reported internalizing and externalizing symptoms would be assessed at T2 as an exploratory outcome.Given the decision to drop the adolescent survey, we decided to add parent-reported child internalizing and externalizing symptoms at T2 as an exploratory outcome.Parent-reported child internalizing symptoms will be assessed using the Mood and Feelings Questionnaire and externalizing symptoms will be assessed using the externalizing subscale of the Child and Adolescent Behaviour Inventory (CABI).Further details can be found in the revised manuscript.3. Timing of T2 data collection: Given the challenging conditions in the study setting, we decided to shift T2 data collection to be 4-months post intervention rather than 3-months post intervention.This change will allow the field teams more time to track and survey participants as well as ensure staff are able to maintain their well-being.4. Other: Additional edits have been made to further clarify the Statistical Analysis section of the protocol.These edits do not substantively change the approach to analysis.

COMMENTS FROM REVIEWERS AND AUTHOR RESPONSES
Reviewer #1 This protocol for a randomized controlled trial addresses an important and understudied area of research-child maltreatment in migrant and displaced families, particularly in low-and middleincome countries (LMICs).It has the potential to fill a significant gap in the literature on the prevention of child maltreatment in vulnerable populations.The protocol clearly outlines the rationale, provides detailed information about the methods (including participants, measures, and procedures), and offers a precise plan for statistical analysis and discussion.The reasoning behind choosing a film-based intervention is clearly articulated, emphasizing its potential for costeffective, large-scale implementation in resource-limited settings.The decision to use a pragmatic, superiority cluster randomized controlled trial will allow for the investigation of the intervention's effectiveness in the "real world."I also appreciate the use of various measures (both parent reports and adolescent reports) to evaluate the primary and secondary outcomes of the intervention.Furthermore, the use of both quantitative and qualitative methods could offer valuable insights about intervention delivery, acceptability, perceived impacts, and potential mechanisms of change.
Overall, I view the protocol very positively and I am looking forward to reading about the results of this important study.
I have only one minor comment: How did the authors of the protocol ensure that the film is adequate for the needs and situations of families with children across such a wide age range, from 4 to 17 years?
Response to reviewer: Thank you for your review and feedback on the protocol.In response to your question, we worked closely with partner organization Sermpanya Foundation on the development of the script to ensure that the characters and parenting scenarios in the film addressed a wide age range and corresponding developmental stages.
The film depicts two families, each with younger children (e.g.infant, 5-6 years) and older children (12-14 years).Scenes in the film depict different parent-child interactions that correspond to the child's age and developmental stage.For example, scenes with younger children depict using play as way to foster learning, while scenes with older children focus on positive parent-adolescent communication to promote problem solving.
We have edited the manuscript as follows to provide further details (please see page 10): "The characters and scenarios depicted in the film reflect different ages and developmental stages to ensure that the film would be relevant to families with children across a wide age range."

Reviewer #2
The manuscript is well-written and addresses the important social issue of child maltreatment through a novel approach, and with a vulnerable population.
My questions and concerns about the manuscript are three-fold: 1) Why submit the article at this stage, before data has been collected and analyzed?While it appears to be a novel approach, the manuscript seems incomplete without an analysis of the results.I would recommend resubmitting the manuscript with the data analysis.
Response to reviewer: Thank you for your review and feedback on the protocol.In response to your question, we are submitting the protocol for publication in line with international commitments to improve research standards by promoting transparency, reducing publication bias, and enhancing the reproducibility of study design and analysis (see for example the UK Medical Research Council policy on open research data: clinical trials and public health intervention studies, October 2016).Upon completion of data collection and analysis, we will prepare and submit a separate manuscript reporting study results.
2) Why are so many different assessment tools used?I added up the possibility of 168 question items or more.Is all of this necessary and relevant to the study's aims?Further rationale and explanation would be helpful, along with an estimate of the number of questions, and the length of time required to implement and respond to the assessments.
Response to reviewer: Thank you for this question.The measures have been carefully selected to rigorously and robustly assess each of the primary, secondary, and exploratory outcomes theorized to be potentially impacted by the intervention.In addition, several measures (e.g.trauma exposure, daily stressors) are included to investigate potential moderating effects -for example, to examine if caregivers who have experienced more trauma benefit more or less from the intervention than caregivers who have experienced less trauma.There are approximately 100 items in the survey, which takes 1-2 hours to complete depending on the participants.This length is consistent with past surveys that the study team has conducted in this setting.We have added details about the survey length on page 15 of the revised manuscript.
3) Why is Burmese the only language being used (rather than Karen, Karenni, Chin, etc.)?Does use of the Burmese language have a potential political subtext for minority groups who might have experienced oppression by the government?You could directly address the demographics within the migrant populations, and the role of language in this type of research.
Response to reviewer: Thank you for raising this very important point.We agree that conducting the study in Burmese only is a limitation and have now included this on page 25 of the revised manuscript.The decision to only use Burmese was due to practical considerations regarding time and resources.Unfortunately we did not have the ability to translate and administer the surveys in multiple languages.